Clinical Trials AFR

The Atrial Flow Regulator is being evaluated for heart failure patients in two ongoing clinical studies (FROST-HF and PROLONGER) and a prospective registry (AFteR), and in an ongoing clinical study for pulmonary arterial hypertension patients (PROPHET). Additional clinical studies are also being planned.

Heart Failure

PRELIEVE Study

Completed patient enrollment in a multicenter Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Heart Failure Patients

PROLONGER Study

Currently enrolling patients in a multicenter study to assess invasive and non-invasive parameters that may predict clinical improvement in patients with congestive heart failure after implantation of the Atrial flow regulator (AFR) device

AFteR Registry

Currently enrolling patients in a multicenter registry to monitor the safety and effectiveness of the Atrial Flow Regulator (AFR) device in patients with heart failure

FROST-HF

Currently enrolling patients in a prospective, randomized, sham-controlled, double-blinded, global multicenter study, to assess the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF).

Pulmonary Arterial Hypertension

PROPHET Study

Currently enrolling patients in a multicenter Pilot Study to Assess Safety and Efficacy of a Novel Atrial Flow Regulator (AFR) in Patients with Pulmonary Hypertension